ARCAD CS041618Recalls & reported problems
Novastep · Compressive staple 18-16-18 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700879501291), received between Oct 25, 2016 and Oct 25, 2016 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break2
- Improper or Incorrect Procedure or Method1
- Patient-Device Incompatibility1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2016Break; Patient-Device Incompatibility
HOSPITAL CALLED NOVASTEP SALES REP ON 29TH SEPTEMBER 2016 AND REPORTED ARCAD 18 COMPRESSIVE STAPLE BREAKAGE. ARCAD 18-16-18 COMPRESSIVE STAPLE WAS DETECTED AS BROKEN BY THE SURGEON DURING THE ANALYSIS OF XRAY PERFORMED DURING A PATIENT FOLLOW UP VISIT. WEIGHT OF THE PATIENT ASSOCIATED TO THE USE OF ONLY TWO ARCAD 18 STAPLES TO PROCEED MTP ARTHRODESIS (TOO WEAK) IS EXPECTED TO BE THE ROOT CAUSE OF THIS BREAKAGE. ASSEMBLY SHOULD HAVE BEEN DONE USING BIGGER STAPLES OR ADDITIONAL DEVICES ASSOCIATED WITH TWO ARCAD 18 COMPRESSIVE STAPLES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6053978 ↗InjuryOct 25, 2016Break; Improper or Incorrect Procedure or Method
DURING A SALES REP VISIT ON (B)(6) 2016 IT WAS REPORTED TO NOVASTEP SALES REP. THAT DURING THE LAST 12 MONTH 3 CASES HAVE CONDUCTED TO ARCAD 18 COMPRESSIVE STAPLE BREAKAGE. THIS IS THE SAME SURGEON FOR THESE 3 CASES. FIRST CASE: ARCAD 18-16-18 COMPRESSIVE STAPLE WAS DETECTED AS BROKEN BY THE SURGEON DURING THE ANALYSIS OF XRAY PERFORMED DURING A PATIENT FOLLOW UP VISIT. THE SURGEON EXPECTS THAT THE USE OF ONLY TWO ARCAD 18 STAPLES TO PROCEED MTP ARTHRODESIS TO BE TOO WEAK. ASSEMBLY SHOULD HAVE BEEN DONE USING BIGGER STAPLES OR ADDITIONAL DEVICES ASSOCIATED WITH TWO ARCAD 18 COMPRESSIVE STAPLES. THE OTHERS 2 CASES HAVE BEEN REPORTED IN REPORT 3010673777-2016-00001, 3010673777-2016-00002.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6053719 ↗
Other Staple, Fixation, Bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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